Bangalore, 28 July 2026: AstraZeneca Pharma India Ltd. (AZPIL) announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for trastuzumab deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion. The approval is for trastuzumab deruxtecan followed by a taxane, trastuzumab, and pertuzumab (THP) indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.
In HER2-positive early breast cancer, treatment before surgery plays an important role in shaping the overall care pathway. It provides an opportunity to assess tumour response, guide post-surgical decisions and, where possible, improve longer-term outcomes. However, with currently used neoadjuvant regimens, pathological complete response (pCR) is achieved in only 39% to 64% of patients, however, these regimens are associated with a range of acute and long-term toxicities. With no new therapies introduced in this setting for more than a decade, there remains a need for neoadjuvant options that can deliver stronger efficacy while reducing treatment burden.
The approval is supported by results from the DESTINY-Breast11 trial. In the study, trastuzumab deruxtecan followed by THP showed the highest reported pCR rate in HER2-positive early breast cancer for a registrational study in the neoadjuvant setting, despite a high prevalence of hormone receptor-positive disease and a high-risk population. The regimen demonstrated a statistically significant and clinically meaningful improvement in pCR rate versus ddAC-THP, with an absolute difference of 11.2% (95% CI 4.0, 18.3). The pCR benefit was observed irrespective of hormone receptor status and disease stage.
Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited said, "Improving outcomes in HER2-positive early breast cancer begins with ensuring that patients can benefit from the most effective treatment approaches at the right point in their care. At AstraZeneca, we believe equitable access to innovation is critical, especially in the early setting where treatment before surgery can help guide the path that follows. This approval supports broader access to a new neoadjuvant option in India and reflects our commitment to helping improve outcomes for more patients through timely access to scientific advances."
Trastuzumab deruxtecan is also approved in India for use in specified settings in metastatic HER2-positive breast cancer, including in combination with pertuzumab in the first-line setting, in HER2-low and HER2-ultralow metastatic breast cancer, in locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma after an anti HER-2 based regimen, and in other unresectable or metastatic HER2-positive (IHC3+) solid tumours after prior systemic treatment where no satisfactory alternative treatment options exist.
This approval broadens the role of trastuzumab deruxtecan in India and adds a new option in the neoadjuvant treatment of HER2-positive early breast cancer.
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- DOI: 10.1016/j.annonc.2025.10.019